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SX-682 + Nivolumab for Pancreatic Cancer

Phase 1
Recruiting
Led By Richard Dunne, MD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Completion of at least 16 weeks of first line chemotherapy without evidence of disease progression
Must not have
Subjects with clinically significant heart disease that affects normal activities
History of myelodysplastic syndromes or myeloproliferative neoplasms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of enrollment until date of death from any cause up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug combo to see what the max dose is that patients can tolerate while still benefiting from the treatment.

Who is the study for?
This trial is for adults over 18 with metastatic pancreatic ductal adenocarcinoma who've completed at least 16 weeks of first-line chemo without the cancer getting worse. They must be able to perform daily activities (ECOG status 0 or 1) and not have brain metastases, active pneumonitis, recent major surgery, other cancers in the last three years, or use immunosuppressants. Participants need functioning organs and can't be pregnant or breastfeeding.
What is being tested?
The study tests SX-682 combined with Nivolumab as a maintenance therapy to find the highest dose patients can tolerate. It's for those whose disease didn't progress after initial chemotherapy. The goal is to see how well they handle this combination treatment and what effects it has on their cancer.
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in various organs, potential liver function changes, fatigue, skin issues, digestive disturbances, hormonal imbalances due to immune system interference by Nivolumab and SX-682.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I completed 16 weeks of initial chemotherapy without my cancer getting worse.
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My cancer is a type of pancreatic cancer that has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have heart disease that limits my daily activities.
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I have a history of blood disorders like MDS or MPN.
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I had major surgery less than 4 weeks ago.
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I am on steroids or other drugs that affect my immune system.
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I have not had any cancer, except for treatable local cancers, in the last 3 years.
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I have cancer that has spread to my brain or its coverings.
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I have a serious heart or brain blood vessel condition.
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I am not using herbal treatments for my condition.
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I haven't had immunotherapy or experimental drugs in the last 4 weeks.
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I have a history of long QT syndrome.
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I have lung disease or had lung inflammation treated with steroids.
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I have lung inflammation that is not caused by an infection.
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I have had Hepatitis B or C.
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I have active tuberculosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of enrollment until date of death from any cause up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of enrollment until date of death from any cause up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerable dose [Safety and Tolerability]
Secondary study objectives
Overall Survival
Progression Free Survival

Side effects data

From 2023 Phase 1 & 2 trial • 12 Patients • NCT04574583
67%
Neutrophil count decreased
67%
Oral hemorrhage
67%
Injection site reaction
67%
Lipase increased
67%
White blood cell decreased
67%
Anemia
67%
Fatigue
33%
Abdominal pain
33%
Edema limbs
33%
Hypokalemia
33%
Lymphocyte count decreased
33%
Memory impairment
33%
Nausea
33%
Upper gastrointestinal hemorrhage
33%
Rectal hemorrhage
33%
Flu like symptoms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301
Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301
Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: SX-682 and NivolumabExperimental Treatment2 Interventions
SX-682 Dose: 25, 50, 100, 200, 400mg BID taken as an oral pill Nivolumab Dose: 240mg, every 2 weeks via intravenous infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SX-682
2020
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Syntrix Biosystems, Inc.Industry Sponsor
13 Previous Clinical Trials
787 Total Patients Enrolled
University of RochesterLead Sponsor
868 Previous Clinical Trials
549,102 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,685 Previous Clinical Trials
4,129,428 Total Patients Enrolled

Media Library

SX-682 Clinical Trial Eligibility Overview. Trial Name: NCT04477343 — Phase 1
Pancreatic Cancer Research Study Groups: Experimental: SX-682 and Nivolumab
Pancreatic Cancer Clinical Trial 2023: SX-682 Highlights & Side Effects. Trial Name: NCT04477343 — Phase 1
SX-682 2023 Treatment Timeline for Medical Study. Trial Name: NCT04477343 — Phase 1
~0 spots leftby Jan 2025
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